Breathing mask arrangement and a forehead support device for same

ABSTRACT

A breathing mask arrangement includes a frame portion, a sealing lip provided to the frame portion and adapted to form a seal with a user&#39;s face, a forehead support provided to the frame portion, and a forehead cushion removably secured to the forehead support. The forehead cushion includes a contact portion having a contact surface adapted to contact a user&#39;s forehead and a connecting structure structured to couple the forehead cushion to the forehead support and allow pivoting and/or tilting movement of the contact portion relative to the forehead support. The connecting structure includes a support foot adapted to be received within a respective opening provided in the forehead support.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/461,901, filed Aug. 27, 2009, allowed, which is a divisional of U.S.application Ser. No. 11/128,399, filed May 13, 2005, now U.S. Pat. No.7,654,263, which is a continuation of U.S. application Ser. No.10/221,572, filed Jan. 28, 2003, now U.S. Pat. No. 7,000,614, which isthe National Phase of International Application PCT/EP02/02877, filedMar. 14, 2002, which designated the U.S. and that InternationalApplication was not published under PCT Article 21(2) in English, whichclaims priority to German Application No. 10201682.8, filed Jan. 17,2002, each of which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The invention concerns a breathing mask arrangement as can be used forexample in the context of CPAP-therapy for treating sleep-relatedrespiratory disturbances. The invention further concerns a foreheadsupport device for a breathing mask arrangement.

BACKGROUND OF THE INVENTION

In the context of what is referred to as CPAP-therapy a patient can besupplied by way of a breathing mask arrangement with a breathable gas;in particular ambient air at a pressure level which is above the ambientpressure level. The respiratory gas which is under pressure makes is itpossible to provide for pneumatic splinting of the upper respiratorytracts and thus to obviate any obstructions. In the course ofimplementing pressure respiration or CPAP-therapy the breathing maskarrangements which are required to supply the respiratory gas areusually worn by the patient over the entire sleep or rest phase of thepatient. The breathing mask arrangement is usually supported by way of asealing Up zone in the region around the nose of the person using themask and by way of a forehead support device in the forehead region ofthe mask user. The holding forces required to apply the breathing maskarrangement can be afforded by a fixing device which for example has aheadband which is passed around the back of the head of the mask user.Under some circumstances, in the region in which the sealing lip deviceis applied and in the contact region of the forehead support device,surface pressures can occur, which result in the level of comfortinvolved, in wearing the breathing mask arrangement being seriouslyadversely affected. In dependence on the individual architecture of theface of the person wearing the mask, considerable mask-pressing forcesare m part required in order to achieve the desired sealing integrity,in that situation, in the region of the zones where the breathing maskbears against the face of the patient, unacceptably clearly visiblepressure points may also be caused in the forehead region.

OBJECT OF THE INVENTION

The object of the invention is to provide a breathing mask arrangementwhich can be reliably fixed in a correct application position and whichis additionally distinguished by a high level of wearing comfort.Attainment of the object in accordance with the invention

In accordance with the invention that, object is attained by a breathingmask arrangement comprising an arch body, a sealing lip means forbearing against the surface of the face of a mask user, a respiratorygas conduit means for feeding respiratory gas to a mask internal spacewhich is defined by the arch body and which is in communication with thenose and/or mouth opening of the user of the mask, and an applicationstructure for application of the sealing lip jointly with the arch body,wherein the application structure has a carrier portion on which arespiratory gas conduit member is mounted.

In that way it is advantageously possible to provide a breathing maskarrangement which is of a robust structure and which can be cleaned inan advantageous manner and which is distinguished by a high level ofsealing integrity.

In accordance with a particularly preferred embodiment of the inventionthe respiratory gas conduit member is in the form of a tube connection.Such a tube connection is preferably made from dishwasher resistantplastic material so that the respiratory gas conduit member can becleaned at comparatively high temperatures and in the processsterilised. The tube connection is preferably of such a configurationthat its inside diameter is in the region of 12 to 34 mm. The tubeconnection can be of a substantially circular or preferably polygonalcross-section. The tube connection can be in the form of a conduit bendwhich provides for a slight change in direction of the flow ofrespiratory gas through an angle in the range of from 0 to 45°.

The conduit member which in particular is in the form of a tubeconnection is preferably releasably mountable to the carrier portion. Alatching device is preferably provided for coupling the respiratory gasconduit member to the carrier portion. In accordance with a particularaspect of the present invention that latching device is advantageouslyin the form of a bayonet or rotational latching device.

The application structure of the breathing mask arrangementadvantageously includes a frame portion which can be releasably coupledto the sealing lip means and/or to the arch body. Preferably the frameportion is designed in such a way that it embraces the arch body in aring or loop configuration. The carrier portion is advantageously Madefrom plastic material and is provided with holding members, by way ofwhich the carrier portion can be coupled for example to a lower web bandarrangement of a headband. Advantageously those holding members are inthe form of holding loops or clips, through which an end portion of theabove-mentioned lower web band arrangement can be passed. The holdingloops are preferably formed integrally with the carrier portion. Theinternal peripheral wall of a through opening formed by the holdingloops is preferably of a configuration which, in regard to the mouldingtool, permits removal of the holding loops from the mould withoutinvolving the use of a sliding pusher member.

The carrier portion provided for fixing the respiration gas conduitmember is advantageously formed integrally with the frame portion. Inthat respect the carrier portion is advantageously designed in such away that it has an insert opening into which the respiratory gas conduitmember can be releasably inserted. The carrier portion is preferablyarranged in such a way that it extends substantially perpendicularly toa frame surface defined by the frame portion.

In the region of the insert opening, the carrier portion preferablyforms those coupling structures which can be brought into engagementwith the respiratory gas conduit member which is in the form of the tubeconnection.

The arch body preferably comprises a coupling portion, by way of whichthe arch body can be sealingly connected to the respiratory gas conduitmember. Preferably the arch body is produced from an easterner materialand fitted with elastic expansion thereof on to a portion of the tubeconnection, which is passed through the insert opening and whichpenetrates to the sealing lip means. Preferably, a peripheral bead orridge is provided on that portion of the tube connection, which extendsas far as the sealing lip means, by means of which peripheral bead thearch body and the tube connection are reliably held in the joinedcondition.

In accordance with a particularly preferred embodiment of the inventionthe arch body is formed integrally with the sealing lip means that wayit is advantageously possible to avoid gaps or joints in thetransitional region between the sealing lip means and the arch body. Inaddition it is advantageously possible for the sealing lip means and thearch body to be inserted in the form of an integral elastomer componentinto the frame portion.

In accordance with a particularly preferred embodiment, particularlyreliable discharge of respiratory gas loaded with CO₂ to the ambientatmosphere is attained in that the arch body is provided with openingsthrough which the respiratory gas which is under pressure in theinternal region of the arch body can escape to the ambient atmosphere.The openings are preferably such that the cross-section thereof enlargesin the outlet direction. Those outlet openings are preferably arrangedin such a way that they are disposed as closely as possible to theregion which, in the position of application of the breathing maskarrangement, is adjacent to the nasal openings of a user of the mask.

In accordance with a particular aspect of the present invention theapplication structure includes a forehead supporting device forsupporting the breathing mask arrangement in the forehead region of theuser of the mask. The forehead supporting device is advantageouslyconnected by way of a pivot device to the frame portion which embracesthe arch body. By virtue of that configuration it is advantageouslypossible for the position of the forehead supporting device to beadapted to the individual architecture or configuration of the face ofthe user of the mask. Preferably the pivot device includes an arcuatetrack guide means by which the forehead supporting device can bevariably positioned.

The respiratory gas conduit member which is preferably releasablycouplable to the carrier portion advantageously forms a docking portwhich for example can also form part of a rotary coupling structure. Itis possible to provide on the docking port further connecting devices,in particular s small tube connections, by way of which for example apressure measuring hose can be coupled to the breathing mask arrangementor possibly an additional supply of oxygen can be effected.

The forehead supporting device is preferably made from a thermoplasticmaterial and provided with a forehead cushion means. The foreheadcushion means is preferably formed by elastomer elements which are of apad-like configuration and which can be coupled by way of a plugconnecting structure to the receiving portion of the forehead supportingdevice, said receiving portion preferably being of a loop-likeconfiguration. In that case the forehead supporting device is preferablydesigned in such a way that the elastomer elements can be fitted to theforehead supporting device at different locations. Preferably theelastomer elements are also of such a configuration that, by virtue ofthe way in which they are fixed to the loop portion, it is also toachieve different positions of the contact regions of the elastomerelements on the forehead of the user of the mask. The elastomer elementsare preferably made from a silicone rubber material and in the region oftheir contact surface are so shaped that transmission of the contactforces to the surface of the forehead of the user of the mask takesplace under a physiologically well compatible surface pressure. That canbe achieved in particular by the elastomer elements being provided, on arear side remote from their contact side, with an eccentrically arrangedsupport foot which permits a tilting movement of the contact portionwhich bears against the user of the mask.

Preferably, also provided on the loop portion are coupling portionswhich permit coupling of the forehead supporting device to an upper nforehead hand arrangement of a headband. Those coupling portions can bein the form of a hand strip. It is also possible for the foreheadsupporting device to be fixed for example by way of a hook-and-loopfastener to a preferably cushioned forehead hand arrangement.

In accordance with a further aspect of the invention, another object ofthe invention is to prevent the occurrence of any pressure points in theforehead region in connection with the use of breathing masks.

In accordance with the invention that object is attained by a foreheadsupport device for a breathing mask comprising a contact dement which isprovided in the application position for bearing against the foreheadregion of a user of the mask, wherein there is provided a holding devicefor holding the contact element movably.

By virtue thereof it is advantageously possible to ensure that abreathing mask arrangement is supported in the forehead region of apatient under a markedly reduced surface pressure against the tissue ofthe patient. The mobility of the contact element, which is provided inaccordance with the invention, means that it can automatically adapt tothe individual curvature of the forehead region of the user of the mask.In that way it is further advantageously possible for the contactelement to afford a large surface area, whereby it is advantageouslypossible to achieve a marked reduction in the surface pressure.

An embodiment of the forehead support device, which is preferred inaccordance with a particular aspect of the present invention, isafforded in that the holder is in the form of a pivotal holder. Thatpivotal holder advantageously permits a tilting movement of the contactelement about at least one axis substantially parallel to the usualcontact orientation. That pivotal holder can preferably be formed by apivot or hinge device which in accordance with a particularly preferredembodiment includes a ball joint. As an alternative thereto or also incombination with that configuration, it is possible for the pivot deviceto be formed by an elastomer structure. The range of movement of theholder of the contact element is preferably in the range of 10-30°. Itis possible to take sufficient account of all possible foreheadarchitectures within that angular range.

In accordance with a particular aspect of the present invention thecontact element is formed from an elastomer material, for example afully transparent or coloured silicone rubber material. Particularly inthis embodiment the contact element is preferably of a pad-like orplate-like configuration. In that case, the contact element ispreferably concavely inwardly curved in such a way that a defineddistribution in terms of surface pressure is afforded when the contactelement is applied to the surface of the forehead, in accordance with aparticularly preferred embodiment of the invention that surface pressureis so selected that, within a predetermined spacing from the edge of thecontact element, there is a substantially uniform surface pressure, withthe surface pressure gradually decreasing outwardly in the edge regionof the contact element.

In accordance with a particularly preferred embodiment of the inventionthe forehead support device includes a plurality of and preferably twomutually adjacently arranged contact elements. The contact elements arepreferably arranged in such a way that in the application position of abreathing mask arrangement, they are positioned above the left and righteyebrows of the user of the mask. The two contact elements arepreferably is connected together by way of a flexible bridge or strapdevice. In that way, it is possible on the one hand to achieve a greaterincrease in the contact area while at the same time the possibility ofthe contact elements twisting relative to each other can he limited in adefined manner. Particularly in this embodiment the two contact elementsare preferably formed integrally with each other. The configuration ofthe contact elements in a plan view is not limited to substantiallycircular external contours. For example it is also possible to adoptelliptical or other polygonal external contours.

The pivot device for pivotally movably mounting the respective contactelement is preferably also formed integrally with the contact element. Adefined pivot character can be achieved by virtue of suitablegeometrical configuration of the pivot device.

The pivot device is preferably arranged in such a way that it isdisposed on or et least near the line of action of a force which extendsthrough a centre point in terms of surface pressure of the respectivecontact element. That still further promotes rendering the distributionof surface pressure uniform.

The contact elements are preferably profiled in such a way that thecontact element is prevented from being applied by suction to thesurface of the forehead of the patient. Suction of the forehead supportdevice on the surface of the forehead of the patient can further also beobviated by the contact element being provided with through bores oralso with passages, through which air can pass into an intermediateregion between the contact element and the forehead of the user of themask.

The ball joint structures advantageously provide for good adaptabilityto the horizontal and vertical configuration of the forehead of the userof the mask. The pivot device—it particular the ball joint means—canalso be designed to be lockable. The pivot device can also preferably betiltable in a particularly advantageous manner about given axes—inparticular about a horizontal axis. The curvature of the contact elementcan be so selected that different radii of curvature are afforded in thehorizontal and vertical directions. The radii of curvature arepreferably smaller than the usual radii of curvature of a forehead.

As an alternative to ball joint structures it is also possible to adoptcardanic suspension means, for example by means of a pivot pin. Theangle of pivotal movement of the pivot device is preferably limited to apredetermined abutment angle. The material properties of the contactelement are preferably so selected that it has a substantiallyanti-bacterial action and possibly acts to promote the healing ofwounds.

Advantageously, a cushion means, in particular a gel body cushion means,or also an air or liquid cushion means, can be provided in the region ofthe contact surface. In that case, by varying the amount of liquid, airor gel used, it is advantageously possible to adjust the position of thebreathing mask relative to the user.

Advantageously the mounting position of the contact element isadjustably variable. As an alternative thereto—or also in combinationwith this feature—it is also possible to provide a plurality of couplingoptions so that it is possible to achieve varying spacings on theforehead, by suitable selective coupling. It is possible to implementcoarse adjustment by for example two, preferably three or also morecoupling options, and to implement preferably stepless fine adjustmentwithin a limited fine adjustment range. It is possible to permit aplurality of permutation options, in which case the individual couplingpermutations result in respectively different settings in terms of thespacing relative to the forehead. It is also possible to provideclamping structures, by means of which stepless adjustment of thespacing relative to the forehead is possible. The coupling means can beso designed that a defined adhesive location is achieved, so that asetting which is individually steplessly adapted is durably maintainedby adhesive means.

In accordance with a particularly preferred embodiment of the inventiona particularly high level of wearing comfort is achieved in that thesurface portions of the contact element, which come into contact withthe surface of the skin of the user of the mask, have a surface which isvelvety matt. In accordance with a particularly preferred embodiment ofthe invention, at least in the region of the contact surface of thecontact element, there is provided a surface structure for affording aself-cleaning effect. Such a surface structure may have for examplelotus leaf surface structures. The contact element may also be providedwith a gel body, at least in the region of the contact surface.

BRIEF DESCRIPTION OF THE DRAWINGS

Further details and features of the invention will be apparent from thedescription hereinafter with reference to the drawings in which:

FIG. 1 shows a perspective view of a breathing mask arrangementaccording to the invention,

FIG. 2 shows a further perspective view of the breathing maskarrangement according to the invention without hose connecting sleeve,

FIG. 3 shows a perspective view of the application structure of thepreviously illustrated breathing mask arrangement,

FIG. 4 shows a perspective view of the application structure with adocking port connected thereto,

FIG. 5 shows a perspective view of an integral member formed from acarrier portion and a frame portion,

FIG. 6 shows a further perspective view of the integral member shown inFIG. 5 to describe the latching device provided for coupling the dockingport,

FIG. 7 shows a side view of the breathing mask arrangement according tothe invention,

FIG. 8 shows a simplified perspective view of a forehead support devicewith two pivotably mounted pad-like contact elements and by way ofindication a breathing mask,

FIG. 9 shows a simplified sectional view to illustrate a preferredembodiment of a pivotably mounted contact element,

FIG. 10 shows a plan view of two contact elements which are formedintegrally with each other, each of which is individually provided witha pivotal mounting means,

FIG. 11 shows a further embodiment of a contact element with a concavelycurved contact surface and a part-spherical portion for pivotablymounting the contact element, and

FIG. 12 shows a sketch to describe a preferred distribution of surfacepressure from a central region of the contact element in its variationfrom a centre region of the contact element towards the edge regionthereof.

DETAILED DESCRIPTION OF THE DRAWINGS

The breathing mask arrangement shown in FIG. 1 includes a sealing lipmeans 1 made from an elastomer material, in particular silicone rubber,and an arch body 2. The sealing lip means 1 is designed in such a waythat it lines a receiving opening provided to receive the nose region ofa user of the mask, and in that situation preferably passes across thebridge of the nose and the upper lip region of the user of the mask. Inthis case the sealing lip means 1 is of a substantially saddle-shapedsilhouette. In this embodiment, the sealing lip means 1 and the archbody 2 are made in one piece from an elastomer material and areaccommodated in a frame portion 3.

The frame portion 3 is made from a plastic material and has holdingclips or loops 4 which are produced integrally therewith. In theapplication position of the breathing mask arrangement the holding loops4 are disposed at cheek level or at the level of the sides of the noseof the user of the mask and permit coupling of a lower web bandarrangement. For reliably coupling the arch body 2 to the frame portion3, there is a retaining structure 5, by way of which the arch body 2 canbe fixed to the frame portion 3 in the joining position by latchingengagement therein. The retaining structure 5 includes a retaining nose5 a which engages over a top side of the frame portion 3.

Provided on the arch body 2 are a plurality of outlet openings 6 for thedischarge of used respiratory as to the ambient atmosphere.

The breathing mask arrangement further includes a carrier portion 7which in this embodiment is formed integrally with the frame portion 3.

A respiratory gas conduit member which here is in the form of a dockingport 8 is releasably fixed to the carrier portion 7. The docking port 8includes an annular flange (not visible here) on to which a hoseconnecting sleeve 9 is rotatably movably fitted. The hose connectingsleeve 9 includes a hose connecting portion 9 a on to which an endportion of a respiratory gas hose can be fitted.

The breathing mask arrangement according to the invention furtherincludes a forehead supporting device 10 which is coupled movably to theframe portion 3 by way of an adjusting device 11.

The adjusting device 11 is of such a configuration that it permits apivotal movement of the forehead supporting device 10 with respect tothe frame portion 3 about the pivot axis X which is shown here. Theadjusting device 11 includes a fixing mechanism, by which the foreheadsupporting device 10 and the frame portion 3 can be fixed in theselected relative position.

The forehead supporting device 10 includes a loop portion 12 to whichforehead cushion elements 14 can be mounted. Provided on the loopportion 12, similarly to the frame portion 3, are holding loops or clips15, for coupling the loop portion 12 to an upper web band arrangement ofa headband provided for fixing the breathing mask arrangement in place.

The forehead cushion elements 14 are made from an elastomer materialand, on their underside 14 a which in the application position facestowards the user of the mask, form a contact surface involving apredetermined distribution in terms of surface pressure. The foreheadcushion elements 14 are each coupled to the loop portion 12 by way of arespective push-in foot 16. The push-in foot 16 is providedeccentrically on the respective forehead cushion element 14 in such away that pivoting the forehead cushion elements 14 about the axis 17 ofthe push-in foot, as indicated by the arrow P, makes it possible toachieve different contact positions for the underside 14 a of theforehead cushion elements 14 on the surface of the forehead of the userof the mask. Different contact positions can be achieved by virtue ofselection of the pivotal position of the forehead cushion element 14 andby virtue of selection of the receiving opening 18 provided to receivethe push-in foot 16. In the embodiment illustrated here, two mutuallyspaced receiving openings 18 are provided in the loop portion 12, foreach of the left and the right forehead cushion elements 14.

The forehead cushion elements 14 can be removed from the loop portion 12by pulling the push-in feet 16 out of the receiving openings as is shownin FIG. 2. In this embodiment, the centre lines of the receivingopenings 18 are spaced from each other by approximately 10 mm. Theeccentricity of the push-in foot 16 on the respective forehead cushionelement 14 (see in that respect FIG. 1) is also about 10 mm. As a resultof the eccentric arrangement of the push-in foot 16 and the spacedarrangement of the receiving opening 18, heightwise variability of theforehead cushion elements in a range of about 30 mm is achievedsubstantially perpendicularly to a line joining the eyebrows of the userof the mask. A variation in the contact position over a range of 20 mmis also possible in a lateral direction, that is to say in the directionof the above mentioned line which joins the eyebrows. The holding loop15 provided for coupling an upper web band arrangement is arranged inthe proximity of the receiving openings 18 in such a way that thethrough opening 15 a defined by the holding loop is covered over towardsthe user of the mask by the forehead cushion element 14.

In the view shown in FIG. 2 the hose connecting sleeve 9 shown in FIG. 1has been removed from the docking port 8. It is possible in this view tosee an annular flange 19 which is formed integrally with the dockingport 8 and which has a plurality of tongue elements 19 a which areelastically deflectable towards the centre of the through passage formedby the docking port 8. Provided on the tongue elements 19 a is aretaining bead or ridge 20 which can be brought into engagement with aninternal peripheral groove provided in complementary relationship on thehose connecting sleeve 9. The geometry of the retaining bead 20, theinternal peripheral groove in the rotational sleeve 9 and the elasticityof the tongue elements 19 a are so matched that the hose connectingsleeve 9 can be withdrawn from the annular flange 19 without involvingthe use of a tool, when a oven pulling force is exceeded. The annularflange 19 and the hose connecting sleeve 9 are also designed to fit insuch a way that the hose connecting sleeve 9 is easily rotatably carriedon the annular flange 19.

In this embodiment the docking port 8 is provided with hose connecting,portions 21, 22, on to which a plug or hose element can be fitted. Thehose connecting portions 21, 22 each form a respective through passagewhich opens into the respiratory gas passage formed in the docking port8. When not in use, the hose connecting portions 21, 22 can be closed bya plug or cap element (not shown) which is preferably fitted infrictionally locking relationship on the hose connecting portions 21,22. In this embodiment the hose connecting portions 21, 22 are arrangedrecessed in a groove which is delimited by two upstanding groove walls23, 24. The docking port 8 is coupled to the carrier portion 7 by way ofa plug-in connecting structure.

The retaining connecting structure for coupling the docking port 8 tothe carrier portion 7, as can be seen from the view in FIG. 3, in thisembodiment, is in the form of a rotary latching or bayonet connectingstructure 25. The bayonet connecting structure 25 includes two mutuallydiametrally opposite retaining bridges 27 which are separated from eachother by insertion recesses 26. In the locking position the retainingbridges 27 come into engagement with two retaining projections which areprovided on a push-in flange portion 28 (FIG. 4) of the docking port.

The carrier portion 7 is formed integrally with the frame portion 3 andin that respect forms the insert opening which is provided to receivethe insert connection 26 and which is partially lined by the retainingbridges 27. Provided in the transitional region between the carrierportion 7 and the frame portion 3 are two guide flanks 30 which are alsoprovided integrally with the frame portion 3 and form part of theadjusting means 11. The guide flanks 30 form an arcuate guide means 31in which a coupling portion 32 of the forehead supporting device 10 isdisplaceably guided. The arcuate guide means 31 and the region of thecoupling portion 32, which is guided therein, are such that the foreheadsupporting device 10 and the frame portion 3 are movable relative toeach other about the pivot axis X already shown in FIG. 1. Provided atthe guide flanks 30 is an actuating zone 33, for applying the releaseforce for moving the adjusting means 11 into a release position. Therelease force can be applied to the actuating zone in particular whengripping around the docking port 8 with the thumb and the index fingerand applying the corresponding fingertips. As an alternative to thearcuate guide means 31 provided here, it is also possible for theadjusting means 11 to be of such a configuration that relative movementis made possible between the forehead supporting device 10 and the frameportion 3 along a path of movement which differs from an arcuate path.It is also possible to mount to the forehead supporting device 10forehead cushion devices which in their structure differ from theforehead cushion elements 14 shown in FIG. 1.

FIG. 4 shows the application structure of the breathing mask arrangementaccording to the invention, in an assembly condition in which thedocking port 8 according to the invention is inserted into the insertopening formed in the carrier portion 7 and correctly fixed in positionby way of the bayonet closure device provided in the region of theinsert opening. In this embodiment, the docking port 8 forms a conduitmember which is in the nature of a pipe bend and by which the flow ofrespiratory gas flowing by way of the hose connecting sleeve 9 (FIG. 1)is diverted through an angle of about 30° towards the tip of the nose ofthe user of the mask. Feeding the respiratory gas in that way to theinternal space in the mask, which is defined by the arch body 2 (FIG.1), provides that the gas advantageously flows over the bridge of thenose of the user of the mask.

The modular structure of the breathing mask arrangement according to theinvention makes it possible to implement a configuration of thebreathing mask arrangement, which takes better account of the respectivesituation of use. The docking port 8 which is fitted into the carrierportion 7 has an insert connecting portion 28 which projects beyond thecarrier portion 7 towards the frame portion 3. An insert opening portionof the arch body 2 can be fitted on to the insert connecting portion 28,with slight elastic expansion. Provided on the insert connecting portion28 is a peripheral bead 34, by which the arch body 2 and the insertconnecting portion 28 are held in a defined joint position. Thatperipheral bead 34 can come into engagement with an internal peripheralgroove correspondingly provided in the arch body 2, or it can fit on aninternal surface of the arch body 2. The carrier portion 7 and thedocking port 8 are of such a configuration that the docking port 8 formsa respiratory gas conduit portion which bridges over the region of thebridge of the nose. That ensures that the field of vision is onlyslightly impaired.

FIG. 5 shows a further perspective view of the integral member formingthe frame portion 3. The guide flanks 30 which are made in one piecewith the frame portion 3 are of such a configuration that application ofa release force to the actuating zones 33 urges the guide flanks 30 awayfrom each other in the region of the arcuate guide means 31. In thepresent embodiment, for that purpose, a lever/tilting effect is producedby an arcuate leg 35. The return movement of the guide flanks 30 in theregion of the arcuate guide means 31 takes place as a consequence of theelasticity of the material involved. The fixing effect can be achievedby virtue of frictionally locking damping of the contact zones of thecoupling portion 32, which are guided between the guide flanks 30. As analternative thereto or in combination therewith, it is also possible toachieve the fixing effect by coupling in positively locking engagement,for example by the adoption of a fine tooth arrangement.

Preferably, there is provided an abutment device which limits themaximum range of pivotal movement of the forehead supporting device 10with respect to the frame portion 3. It is possible for that abutmentdevice to be so designed that, for example by increasing the actuatingforces applied to the actuating zone 33, the abutment device is movedinto a condition in which the forehead supporting device 10 can beseparated from the pivot structure connected to the frame portion 3.

The view illustrated in FIG. 5 also shows an outwardly recessed region36 in the frame portion 3, which improves positioning and fixing of thearch body 2 in the frame portion 3. Positioning of the arch body 2 inthe frame portion 3 is further promoted by two fixing plates 37 whichare provided in: the region of the holding loops 4 at the underside ofthe frame portion 3 and which engage into clamping pocket portionsprovided in the transitional region of the sealing lip means 1 in thearch body 2. The frame portion 3 is of a substantially saddle-shapedsilhouette and attains its maximum width in a region of the frameportion 3, which in the application position of the breathing maskarrangement is approximately at the height of the sides of the nose ofthe user of the mask. The holding loops 4 extend upwardly from that zoneB of maximum width to the region of the eyes of the user of the mask.The inward edges of the through openings which are bordered by theholding loops 4 are of a rounded configuration in order to prevent theband portions which are passed through those openings from possiblybeing chafed through. This view again shows the latching device adaptedfor fixing the docking port in the carrier portion 7.

FIG. 6 shows the fixing plates 37 which are provided at the underside ofthe frame portion 3, from another perspective. The fixing plates 37 areof a thickness t as measured transversely to the joining direction inthe range of from 0.8 to 3 mm. The fixing plates are of a taperedconfiguration in the joining direction. The fixing plates 37 and inparticular also the internal peripheral region of the frame portion 3,which region bears against the arch body 2, can be provided with aprofiling which still further assists with coupling of the arch body.Preferably, fine profile grooves extending in the peripheral directionof the frame portion 3 are provided on the frame portion 3 and on theportion of the arch body 2, which bears thereagainst.

The bayonet connecting structure 25 on the carrier portion 7 includes anend abutment 38 for defining the end position of the docking port 8 inthe coupling position. In this embodiment the bayonet connectingstructure 25 is designed in such a way that the maximum fixing force isachieved in the end position defined by the end abutment 38.

FIG. 7 shows the breathing mask arrangement according to theinvention—with the exception of the forehead cushion elements 14 (FIG.11 in the completely assembled condition, from the direction of thepivot axis X. As can be seen in that view the docking port 8 which naccordance with the invention can be releasably inserted into thecarrier portion 7 forms a coupling element for coupling the elastomerarch body 2 to a rotatably supported hose connecting sleeve 9, by whichthe feed flow of respiratory gas is deflected through an angle α whichin this embodiment is 32°.

The docking port 8 can be selected from a set which includes a pluralityof docking ports 8 and forms an interface member by which the arch body2 can be coupled to different hose systems. Compatibility with differentrespiratory gas conduit systems can also be ensured by way of the hoseconnecting sleeve 9 which is fitted on to the docking port 8. It ispossible to provide a plurality of sealing lip means which arerespectively adapted to given types of faces and to achieve aconfiguration which is appropriate to the requirements involved, for thebreathing mask arrangement according to the invention, in that anelastomer element which takes particularly good account of theindividual facial architecture of the user of the mask and whichcomprises the sealing lip means 1 and the arch body 2 is integrated intothe mask arrangement according to the invention. It is also possible toprovide a plurality of variants of the forehead support device, whichhowever are compatible with the adjusting means 11, and to fit the maskarrangement according to the invention with a variant of the foreheadsupporting device 10 which takes particularly good account of theindividual facial architecture. As an alternative to the foreheadcushion elements shown in FIG. 1, the forehead supporting device 10 mayalso be fitted with other kinds of forehead cushion devices forcushioned contact against the forehead of the user of the mask. It ispossible to integrate cushion devices of that kind, for example into anupper forehead band arrangement, and to fit the forehead supportingdevice on to that cushioned forehead band arrangement, for example byway of a hook-and-loop fastener structure.

The invention is not limited to the preceding embodiment. By way ofexample, it is also possible to fit into the frame portion 3 which isdesigned in accordance with the invention, an arch body 2 which is notmade from an elastomer material,

The forehead support device shown in FIG. 8 has a holding device 41 forpivotably holding a contact element 42. The holding device 41 for thatpurpose includes a pivotable holder 43 which here has a plurality offixing elements 44 which form part of a ball joint arrangement.

In the embodiment illustrated here, the contact element 42 is of aplate-like configuration and is formed from an elastomer material, herefully transparent silicone rubber. The contact element 42 is mountedtiltably about at least two axes in space by way of the fixing elements44. In order to ensure as easy mobility as possible of the contactelement 42, provided between the fixing elements 44 and a fixing shankportion (not visible) of the contact element 42 is a ring body which hasa spherical external surface (details in relation thereto will bedescribed more fully with reference to FIG. 9).

The holding device 41 further includes a coupling portion 45 forcoupling the holding device 41 to a breathing mask 46.

In the embodiment illustrated here the coupling portion, 55 is in theform of a ringlike element which can be fitted directly on to aconnecting portion 47 of the breathing mask 46, the connecting portion47 being of a correspondingly complementary configuration. In theembodiment illustrated here the holding device 41 is provided with afixing portion 48 and can be connected by way thereof to a headband.

FIG. 9 shows a preferred embodiment of the contact element 42. Thecontact element 42 is formed from an elastomer material and has acontact surface 49 which is slightly concavely curved. The contactelement 42 is provided with a plurality of fine through bores 50 throughwhich pressure equalisation with the ambient atmosphere can be achievedin respect of the intermediate space possibly defined between thecontact element 42 and the forehead of the patient. That advantageouslyprevents the contact element 42 from being sucked against the foreheadregion of the patient.

In the embodiment illustrated here the contact element 42 has a shankportion 51. Provided on the shank portion 51 is a ring element 52 whichforms a spherical external surface. In conjunction with that ringelement 52, this arrangement affords a comparatively easily movable balljoint device. As an alternative thereto it is also possible to foregothe ring element and to provide the corresponding spherical portiondirectly on the shank portion 51 of the contact element 42.

The embodiment of the invention shown in FIG. 10 has two contactelements 42 which are connected together by way of an integral centralbridge or strap 54. The central strap 54 is so designed that it stillpermits pivotal movement and tilting movement of the two contactelements 42 relative to each other over a sufficient angular range. Thespacing of the centres of the two contact elements 42 from each otherpreferably approximately corresponds to the distance between the eyes ofthe user of the mask.

FIG. 11 shows a further embodiment of a contact element 42, in whichcase tiltability of the portion of the contact element, which forms thecontact surface, is achieved by way of an elastomer structure 55 whichhere is formed integrally with the contact element 52. In the embodimentillustrated here the elastomer structure includes a substantiallyspherical internal space which can be fitted on to a spherical trunnionportion, with temporary elastic expansion. In the embodiment illustratedhere the contact element also has a concavely curved base body which isflattened when the contact element is appropriately fitted in position.

The curvature of the base body of the contact element is preferably soselected that a defined distribution in terms of contact pressure isafforded when it is applied to a flat surface. That distribution inrespect of contact pressure is shown by way of example in FIG. 12. Thelower curved line a1 in this case symboiises the contact surface of thecontact element in its initial position. The line a2 which is shown heras being straight symbolises the contact surface of the contact element42, when appropriately deformed in the application position. Thedistribution in terms of surface pressure, which is indicated here insimplified form by an assembly of arrows 56, occurs in the context ofdeformation of the contact surface of the contact element. Thedistribution in terms of surface pressure is selected here in such a waythat, starting from the centre Z IC towards the edge region, there isinitially a substantially uniform distribution in terms of surfacepressure, with the surface pressure gradually decreasing in the regionof r/5 towards the edge R.

The invention is not limited to the embodiments described hereinbefore.For example, it is also possible, in a departure from the plate-shapedconfiguration selected here, for the forehead contact elements to be ofa rectangular or polygonal configuration.

The invention claimed is:
 1. A breathing mask arrangement, comprising: aframe portion; a sealing lip provided to the frame portion and adaptedto form a seal with a user's face; a forehead support provided to theframe portion; and a forehead cushion removably secured to the foreheadsupport, the forehead cushion including a contact portion having acontact surface adapted to contact a user's forehead and a connectingstructure structured to couple the forehead cushion to the foreheadsupport and allow pivoting and/or tilting movement of the contactportion relative to the forehead support, the connecting structureincluding a support foot adapted to be received within a respectiveopening provided in the forehead support.
 2. A breathing maskarrangement according to claim 1, wherein the forehead support includesarm elements adapted to support the forehead cushion, each arm elementincluding an end portion that provides an opening through which aportion of an upper headband arrangement is structured to pass.
 3. Abreathing mask arrangement according to claim 2, wherein the foreheadsupport is T-shaped.
 4. A breathing mask arrangement according to claim3, wherein the forehead cushion is formed of an elastomeric material. 5.A breathing mask arrangement according to claim 4, wherein the contactportion includes a pad like configuration.
 6. A breathing maskarrangement according to claim 5, wherein the contact surface of thecontact portion is concavely inwardly curved.
 7. A breathing maskarrangement according to claim 6, wherein the forehead cushion includestwo forehead cushions.
 8. A breathing mask arrangement according toclaim 7, wherein the two forehead cushions are connected with each otherby a flexible bridge portion.
 9. A breathing mask arrangement accordingto claim 8, wherein the two forehead cushions are formed integrally withone another.
 10. A breathing mask arrangement according to claim 9,wherein each forehead cushion includes at least one hole or passagethrough the contact surface.
 11. A breathing mask arrangement accordingto claim 10, wherein at least a surface portion of the forehead cushionadapted to contact with the skin of the mask user has a velvety mattsurface.
 12. A breathing mask arrangement, comprising: a frame portion;a sealing lip provided to the frame portion and adapted to form a sealwith a user's face; a forehead support provided to the frame portion;and a forehead cushion removably secured to the forehead support, theforehead cushion including: a contact portion having a contact sideproviding a contact surface and a rear side, wherein the contact portionis constructed to pivot and/or tilt relative to the forehead support inuse; and a support foot provided to the rear side of the contactportion.
 13. A forehead cushion for a forehead support of a breathingmask arrangement, the forehead cushion comprising: a cushion elementincluding a contact surface adapted to contact a patient's forehead andprovide a distribution of contact force; and a coupling element providedto the cushion element, the coupling element adapted to couple thecushion element to the forehead support, wherein the cushion element andthe coupling element comprise an integral construction of elastomericmaterial, wherein the cushion element is movable with respect to thecoupling element to achieve different contact positions on the patient'sforehead, and wherein the forehead cushion includes two foreheadcushions connected with each other by an integral flexible bridgeportion, the integral flexible bridge portion structured to allowpivotal and tilting movement of the two forehead cushions relative toeach other over an angular range.
 14. A breathing mask arrangement,comprising: a frame; a seal provided to the frame and adapted to receiveat least a nose region of a mask user; a forehead support provided tothe frame; and the forehead cushion according to claim 13 coupled to theforehead support.
 15. A breathing mask arrangement according to claim12, wherein the forehead support includes arm elements adapted tosupport the forehead cushion, each arm element including an end portionthat provides an opening through which a portion of an upper headbandarrangement is structured to pass.
 16. A breathing mask arrangementaccording to claim 15, wherein the forehead support is T-shaped.
 17. Abreathing mask arrangement according to claim 16, wherein the foreheadcushion is formed of an elastomeric material.
 18. A breathing maskarrangement according to claim 17, wherein the contact portion includesa pad like configuration.
 19. A breathing mask arrangement according toclaim 18, wherein the contact surface of the contact portion isconcavely inwardly curved.
 20. A breathing mask arrangement according toclaim 19, wherein the forehead cushion includes two forehead cushions.21. A breathing mask arrangement according to claim 20, wherein the twoforehead cushions are connected with each other by a flexible bridgeportion.
 22. A breathing mask arrangement according to claim 21, whereinthe two forehead cushions are formed integrally with one another.
 23. Abreathing mask arrangement according to claim 22, wherein each foreheadcushion includes at least one hole or passage through the contactsurface.
 24. A breathing mask arrangement according to claim 23, whereinat least a surface portion of the forehead cushion adapted to contactwith the skin of the mask user has a velvety matt surface.
 25. Aforehead cushion according to claim 13, wherein the cushion element andthe coupling element are integrally formed as a one-piece structure. 26.A forehead cushion according to claim 13, wherein the coupling elementis structured to allow pivoting and/or tilting movement of the cushionelement.
 27. A forehead cushion according to claim 13, wherein thecushion element includes a pad like configuration.
 28. A foreheadcushion according to claim 13, wherein the contact surface of thecushion element is concavely inwardly curved.
 29. A forehead cushionaccording to claim 13, wherein the coupling element includes a push-infoot adapted to be received within a respective opening provided in theforehead support.